english.prescrire.org > Spotlight > Archives : 2010 > Rosiglitazone (Avandia°; and in combination with metformin in Avandamet°): a market withdrawal that has been 8 years in coming

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Rosiglitazone (Avandia°; and in combination with metformin in Avandamet°): a market withdrawal that has been 8 years in coming

The European Medicines Agency recommended on 23 September 2010 that rosiglitazone be withdrawn from the market. Yet the data published in 2010 have only confirmed the risks that were apparent as soon as rosiglitazone came onto the market in 2002.

In the summer of 2010, two more studies confirmed that rosiglitazone (Avandia°; and  in combination with metformin in Avandamet°) exposes diabetic patients to increased cardiovascular risks, the exact opposite of what treatments for diabetes are trying to achieve.

A systematic review of 56 clinical trials (35,000 patients) evaluating rosiglitazone with a follow-up of more than 24 weeks and including cardiovascular events confirmed a statistically significant increase in the risk of myocardial infarction.

In a study of data from an American health insurance provider, compared to pioglitazone (Actos°), rosiglitazone appeared to increase, in a statistically significant manner, the risk of stroke, congestive heart failure and death (what's more, pioglitazone has no demonstrated effectiveness in cardiovascular prevention).

These risks, and others, were already apparent in the 2002 marketing application, and totally unjustified in the absence of any proof of efficacy in preventing complications from diabetes.

The European Medicines Agency has taken 8 years to finally reverse its unwise decision to authorise the sale of rosiglitazone.

In practice, patients and healthcare professionals alike should take notice of the fact that drugs are sometimes authorised for sale in an unwise or premature manner.
©Prescrire 1 October 2010

Source: "Rosiglitazone : la triste saga continue" Rev Prescrire 2010; 30 (324): 742.

For more information:
Do not use glitazones
either alone or in combination
for treatment of diabetes
Prescrire Int 2008;
17 (97): 189.
Avoid prescribing glitazones
to diabetes patients, either
alone or in combination
Prescrire Int 2007;
16 (90): 145.
Rosiglitazone et pioglitazone,
two oral antidiabetics:
both poorly assessed
Prescrire Int 2002;
11  (62): 170.
In the October issue of
Prescrire International;
No glitazones for
diabetic patients!